Description

Doxorubicin Imp B HBr Salt is a high-purity chemical reference standard, specifically the hydrobromide salt of a key process-related impurity of the anthracycline chemotherapeutic agent, Doxorubicin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily utilized by research institutions, quality control laboratories, and API manufacturers involved in the development and production of oncology medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Doxorubicin Impurity B in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Doxorubicin.

Basic Information

Product Name	Doxorubicin Imp B HBr Salt
CAS No.	148218-14-8
Molecular Formula	C27H30BrNO11 • HBr
Molecular Weight	689.35 g/mol (for the HBr salt)
Synonyms	Doxorubicin Impurity B Hydrobromide; Doxorubicin Related Compound B HBr; 7-Deoxydoxorubicinone hydrobromide; 7-Deoxydoxorubicin aglycone HBr; Adriamycin Impurity B HBr Salt; (7S,9S)-7-((2R,4S,5S,6S)-4-Amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrobromide
EINECS	Contact for details

Quality Control

Our Doxorubicin Imp B HBr Salt is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via NMR and Mass Spectrometry, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, residual solvents, and water content (KF).

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	Orange to red powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.